A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Two GSK3862995B Formulations in Healthy Participants

NCT07789899 | Recruiting Phase 1

• 1 other identifier: 301202
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two formulations of the investigational medicine GSK3862995B in healthy adults. The study aims to assess how the body absorbs and processes the medicine, and to evaluate its safety and tolerability.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

GSK3862995B; Pharmacokinetics; Healthy Volunteers; Phase 1; Safety and Tolerability

Outcome Measures

Primary Outcomes (4)

• Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-t)] of GSK3862995B

  From pre-dose on Day 1 through Week 36

• Maximum Observed Serum Concentration (Cmax) of GSK3862995B

  From pre-dose on Day 1 through Week 36

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 49

• Number of Participants With Clinically Significant Changes in Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) Findings

  Up to Week 36

Study Arms (2)

GSK3862995B Formulation A

EXPERIMENTAL

Healthy participants will receive GSK3862995B Formulation A.

Drug: GSK3862995B

GSK3862995B Formulation B

EXPERIMENTAL

Healthy participants will receive GSK3862995B Formulation B.

Drug: GSK3862995B

Interventions

GSK3862995B DRUG

GSK3862995B will be administered.

GSK3862995B Formulation A; GSK3862995B Formulation B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who are generally healthy as determined by medical evaluation including medical history, physical examination laboratory tests, and cardiac monitoring
• Body weight of at least 50.0 kilogram (kg) for male participants or at least 45.0 kg for female participants
• Body Mass Index (BMI) within the range of 18.0 to 32.0 kilogram per square meter (kg/m\^2) (inclusive)
• Male, or female of non-childbearing potential (PONCBP)

You may not qualify if:

• Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
• A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, tuberculosis, hepatitis B or C, shingles) or non-respiratory acute infections that required antimicrobial treatment within 4 weeks before screening
• Abnormal blood pressure (as determined by the investigator)
• Symptomatic herpes zoster within 3 months prior to screening
• Significant allergies to humanized monoclonal antibodies
• Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
• Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• Breast cancer within the past 10 years
• Alanine transaminase (ALT) greater than (\>)1.0x upper limit of normal (ULN)
• Total bilirubin \>1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5 x ULN as long as direct bilirubin is less than or equal to (\<=) 1.5 x ULN
• Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• A clinically significant abnormality in the average of triplicate 12-lead ECG readings performed at screening

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, CB2 2GG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): September 7, 2027
• Study Completion (Estimated): September 7, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

GB (1)